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CompletedNCT03392259Updated Nov 2, 2026

Usefulness of Cardiovascular Disease (CVD) Management Solution

An interventional study of Smartphone app in Cardiovascular Diseases, sponsored by Seoul National University Hospital. Completed at 2 sites in South Korea. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention

Updated Nov 2, 2026Now CompletedFirst site in South Korea+4 moreGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
666
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

Study summary

We previously developed the smartphone app (Heart4U) which is coupled with electronic medical record system in Seoul National University Bundang Hospital. In this study, we aim to evaluate clinical usefulness of smartphone app regarding the control of conventional risk factors in patients with history of cardiovascular disease.

02

Conditions studied

  • Cardiovascular Diseases
03

In context

Cardiovascular Diseases

5,370 studies on the registry are indexed under Cardiovascular Diseases; 940 are open to participants now.

This study's enrollment of 666 is above the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Browse Seoul National University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with atherosclerotic cardiovascular diseae

    1. history of cardiovascular disease (acute myocardial infarction, unstable angina, stable angina)
    2. history of revascularization including percutaneous coronary intervention, peripheral angioplasty or bypass surgery
    3. history of stroke
    4. history of peripheral arterial disease presumed to be of atherosclerotic origin
  • Patients who have smartphone and can use app by themselves
  • Patients who can speak and read Korean language

Exclusion criteria

Exclusion Criteria:

  • Patients with evidences of delirium, confusion or impaired consciousness
  • Patients who are not familiar to smartphone or app
  • Patients who are not supposed to follow the study protocol adequately.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
666 participants (actual)

Study arms

  • No intervention
    Control group

    conventional treatment

  • Experimental
    App group

    conventional treatment + use of smartphone app.

    Behavioral: Smartphone app

Interventions

  • BehavioralSmartphone app

    Installment and use of smartphone app

06

What researchers measure

Primary outcomes

  1. Change of 10-year ASCVD risk (10-year ASCVD risk at 6 months - 10-year ASCVD risk at baseline)

    delta 10-year ASCVD risk between baseline and 6months, %

    Time frame: 6 months

Secondary outcomes

  1. Systolic blood pressure

    automated blood pressure, mmHg

    Time frame: 3 & 6 months

  2. Diastolic blood pressure

    automated blood pressure, mmHg

    Time frame: 3 & 6 months

  3. lipid profiles (total cholesterol, LDL, HDL)

    lipid profiles at 6 months, mg/dL

    Time frame: 6 months

  4. body mass index

    body mass index at 6 months, kg/m2

    Time frame: 6 months

  5. smoking rate

    smoking rate at 6 months, %

    Time frame: 6 months

  6. degree of moderate physical activity

    Godin Leisure-Time Exercise Questionnaire, total score (0-7)

    Time frame: 6 months

  7. depression scale questionnaire

    Patient Health Questionanaire-9, total score 27 (0-27)

    Time frame: 6 months

  8. drug compliance

    Medication Adherence Rating Scale (MARS), total score 10 (0-10)

    Time frame: 6 months

  9. App service satisfaction survey

    Patient Activation Measure-13, total score 39 (0-39)

    Time frame: 6 months

07

Study locations

2 sites
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do 463707, South Korea
  • Seoul National University Bundang Hospital
    Seongnam, Seongnam 463707, South Korea
08

References and documents

Publications

  • Kang SH, Baek H, Cho J, Kim S, Hwang H, Lee W, Park JJ, Yoon YE, Yoon CH, Cho YS, Youn TJ, Cho GY, Chae IH, Choi DJ, Yoo S, Suh JW. Management of cardiovascular disease using an mHealth tool: a randomized clinical trial. NPJ Digit Med. 2021 Dec 3;4(1):165. doi: 10.1038/s41746-021-00535-z. PubMed 34862449 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Feb 2019, 11 months.

Of 1,077 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 11 months is below that.

Counting every sponsor, half of 1,216 studies reached it within 26 months; a quarter within 12 and three quarters within 49.

Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 1, 2018
First posted
Jan 5, 2018
StartActual
Feb 19, 2018
Primary completionActual
Feb 1, 2019
CompletionActual
Sep 1, 2019
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Status unknown→Completed
changed Nov 2, 2026
Sites
2 sites added, 2 sites removed — first site in South Korea; no longer in Korea, Republic of
Show 2 added (2 South Korea)
  • Seoul National University Bundang Hospital · Seongnam-si, South Korea
  • Seoul National University Bundang Hospital · Seongnam, South Korea
Show 2 removed
  • Seoul National University Bundang Hospital · Seongnam, Korea, Republic of
  • Seoul National University Bundang Hospital · Seongnam, Korea, Republic of
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Status unknown→Completed
    2 sites added, 2 sites removed — first site in South Korea; no longer in Korea, Republic of
    Show 2 added (2 South Korea)
    • Seoul National University Bundang Hospital · Seongnam-si, South Korea
    • Seoul National University Bundang Hospital · Seongnam, South Korea
    Show 2 removed
    • Seoul National University Bundang Hospital · Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital · Seongnam, Korea, Republic of
    + 5 other changes: verification date, date precision, contact details, references and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03392259
Lead sponsor
Seoul National University Hospital
Responsible party
Jung-Won Suh (Professor, Seoul National University Hospital) — Principal investigator
First posted
Jan 5, 2018
Start date
Feb 19, 2018
Primary completion
Feb 1, 2019
Completion
Sep 1, 2019
Last update
Nov 2, 2026

Study contacts

Jung-Won Suh, MD
principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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